Health Research Group Publications

Founded in 1971 by Sidney Wolfe, M.D. and Ralph Nader, Public Citizen’s Health Research Group promotes research-based, system-wide changes in health-care policy and drug safety. The work that we have done since 1995 is listed on this page in chronological order.

In an invited commentary for the Association of Health Care Journalists’ (AHCJ’s) Sunshine Week, Dr. Michael Carome, director of Public Citizen’s Health Research Group, discuss Public Citizen’s updated report cataloging all major financial settlements that the pharmaceutical industry has been forced to sign with federal and state governments from 1991 through 2017 for illegal activities.

Public Citizen published a report that catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2017. The report found that drugmakers entered into 412 settlements totaling $38.6 billion in criminal and civil penalties, but that the number and size of federal and state settlements against the pharmaceutical industry remained low in 2016 and 2017, with federal criminal penalties nearly disappearing.

We applaud the House members who voted against the seriously flawed False Hope legislation, which would have created a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective.

In a letter to the U.S. House of Representatives, Public Citizen strongly opposed the “Right to Try Act of 2018.” Although the bill has several improvements over the Senate-passed version of this legislation (S. 204), it still has fundamental flaws that make it dangerous for patients. In particular, the bill would offer false hope to patients by creating a dangerous pathway for access to experimental drugs and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.

Public Citizen strongly opposes the newest version of the “False Hope” Act (the “Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018”). Although the legislation has several improvements over the U.S. Senate-passed version (S. 204), the bill still would offer false hope to patients by creating a dangerous pathway for access to experimental medications and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.

Public Citizen submitted a supplement to its petition the Food and Drug Administration (FDA) to ban the sale of all medication containing the widely prescribed angiotensin II receptor blocker (ARB) olmesartan medoxomil because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss. Since the submission of our petition, a new large cohort study was published that provides additional evidence showing that use of olmesartan is associated with a higher rate of sprue-like enteropathy compared with the use of other ARBs.

Public Citizen sent a letter to Senator Chuck Grassley urging him to broadly examine the adequacy of the Office for Human Research Protections’ (OHRP’s) compliance oversight activities and demand that the agency cease abusing its discretion when deciding whether to initiate evaluations of noncompliance allegations. The letter noted that OHRP now routinely bypasses its own procedures for investigating allegations of misconduct, which in turn signals to the research community that there is little chance the agency will investigate even serious allegations of regulatory violations.

Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.

Public Citizen sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose legislation that would further erode the restrictions on the promotion of drugs for unapproved (off-label) uses that have been approved by the Food and Drug Administration for at least one use. The bill would threaten patient health and safety by undermining the current regulatory regime for ensuring that drugs are safe and effective for each intended use.